1. Field of the Invention
The present invention relates, in general, to devices and related methods for using those devices in the relieving and/or treating of pain, discomfort, and/or inflammation in the pelvic region using targeted pressure and temperature delivery. More particularly, the present invention relates to devices and methods for using those devices to deliver targeted pressure and temperature therapy internally to patients within their rectal or vaginal cavities.
2. Relevant Background
Many people suffer from pelvic floor dysfunction, painful bladder syndrome, vulvodynia and other non-infectious pelvic syndromes that cause them to experience pain or discomfort with intercourse, urination, defecation, or other physical activities. In some cases, pain and discomfort symptoms can occur sporadically or chronically without the particular suffering person being readily able to identify activities as potential causes for the symptoms. There is much speculation and research in the medical community that such non-infectious pelvic syndromes may be at least partially caused by muscles in the pelvic area (and the “pelvic floor” muscles in particular) that are too tight, strained or cramping. This is believed to cause these muscles to spasm or even to bear upon or pinch sensitive nerve bundles in the pelvic area, causing combinations of localized, generalized and referred pain and discomfort sensations.
In situations where strengthening or relaxing of the pelvic floor muscles or drug therapy does not resolve the patient's pelvic issues over time, surgical approaches are sometimes tried. For example, U.S. Pat. No. 6,862,480 describes a surgery entailing implanting a device for treating pelvic disorder that comprises an electronic implant, which includes a sensor, a microchip, and electrostimulator. The implant is adapted to sense muscle spasms and apply electrical stimulation through one or more electrodes to treat the disorder. As appropriate, the control unit may configure the current applied by the electrodes so as to treat various pelvic dysfunction related disorders, such as stress incontinence, fecal incontinence, interstitial cystitis, urine retention, or other sources of pelvic pain or discomfort. The use of the implant described in this patent, however, requires the patient to undergo a painful surgery, thus limiting its attractiveness and use significantly.
In situations where more traditional physical therapy or drug therapies do not resolve the patient's pelvic condition or disorder, there is a desire for medical providers to have exhausted all conservative treatment approaches before invasive therapies, such as surgery described in U.S. Pat. No. 6,862,480, are tried. In this regard, there is much recent research regarding so-called “trigger-points” and “tender points” for the cause of pain and discomfort. Myofascial tissue (also called “fascia”) wraps around muscle tissue, muscle fibers, bundles of fibers, and the muscles themselves, and then continues on to form tendons and ligaments. When muscular dysfunction is present, muscles contract, or cramp, to varying degrees, which is known as “going into spasm.” Ordinary muscle cramps and contractions release with movement, that is, stretching of the affected musculature. When the muscle is locked into a deep and painful spasm, it is said to form a “trigger point” or “tender point.” These points do not release with stretching. Instead, they are locked into a strong state of contraction. This contraction is essentially a localized hardening of the muscle tissue and associated fascia.
To the touch, trigger and tender points feel like hardened knots in the otherwise softer surrounding tissue. Trigger points and tender points are generally distinguished from one another semantically in that they are classified as trigger points if they “refer” pain or discomfort sensations to other parts of the body or alternatively as tender points if they only cause localized pain or discomfort. Trigger points located in the pelvic floor muscles, due to the various nerve bundles located in that region, can cause referred pain to the bladder, urethra, vagina, vulva, testicles, rectum, and other areas of the pelvic region. When a muscle develops a trigger point (e.g., goes into spasm), it can compress or pinch different nerves, thereby sending messages of pain or other discomfort to the brain. Since nerves can pass through many muscles, sometimes the pain is “felt” in a muscle other than the originating site, causing a referred pain situation. Trigger points in particular are now widely speculated to cause referred pain for a variety of medical conditions, disorders, and syndromes causing or otherwise associated with pelvic pain, discomfort, or dysfunction.
As appreciation of the trigger point theory of pain and discomfort grows, many medical professionals are beginning to prescribe physical therapy sessions to treat or resolve trigger and tender points, in addition to or instead of drug and surgical therapies, as part of a regimen for treating various non-infectious pelvic syndromes and symptoms of pain, discomfort, or inflammation in the pelvic region. Myofascial trigger point therapy is one such physical therapy technique. It involves the systematic application of pressure to tender muscles and myofascial tissue in order to relieve pain, discomfort, and other symptoms of dysfunction with the goal of returning the muscles and fascia to their normal, relaxed states.
Myofascial trigger point therapy is a massage-type physical therapy technique that releases “trigger points” in the muscles in the pelvis or other areas. Trigger point therapy is the application of sustained, direct pressure onto a trigger point. In practice, this direct pressure is often repeatedly applied, and at different angles, to an identified trigger point. One theory regarding the mechanism of action is that the applied pressure interrupts various neural signals that cause one or more of the spasm and/or the pain. In any event, such pressure has been found to ultimately lengthen the muscle into its normal state and break spasm-pain-spasm cycles that cause referred and/or localized pain. It also enables the myofascial tissue to release any constriction, and return to its normal state, preventing further spasms.
In the particular case of utilizing myofascial trigger point therapy for the treatment of pelvic region syndromes and disorders, it is the case that many of the suspect pelvic floor muscles are most directly or most easily accessed internally. Given the difficulty of accessing internal trigger points in the pelvic floor muscles, the patients are often referred by their health care provider to a physical therapist that is specially trained to do internal myofascial trigger point release therapy. Oftentimes, such therapists will require the patient to perform exercises or follow-up therapies at home. Problems arise, however, when a particular patient does not have available a partner to assist in the home therapy. Anatomical limitations prevent such patients from being able to manually access the trigger points at home without an appropriately adapted treatment tool. Conventionally available tools, however, are not well suited for such purposes.
Many conventional physical therapy devices suitable for home use by a patient and designed for the pelvic region are particularly designed for general strengthening of the pelvic floor muscles (such as for incontinence or constipation), and not for providing targeted internal therapy such as trigger point therapy. For example, the performance of exercises to strengthen and/or retrain the pelvic floor muscles (e.g., Kegel exercises) can be augmented with various commercially available intra-vaginal and/or intra-anal devices adapted to facilitate or improve the performance of the pelvic exercises. Such intra-vaginal and/or intra-anal devices have included weighted apparatus such as intra-vaginal cones. Patients are instructed to insert the weighted and tapered cone into the vagina or rectum and squeeze their pelvic muscles in order to retain the device for a certain length of time. Other types of prior art devices include electromyographic (EMG) transducers or sensors which are insertable into or placed just outside of the vagina and/or anus to obtain EMG data indicative of baseline pelvic floor muscle tone and/or contraction(s) of the pelvic floor muscles during the performance of specific muscle contraction exercises. Such EMG data may be usable for diagnostic purposes as well as for monitoring the performance and/or effect of muscle training exercises. Thus, such conventional devices available on the market designed for home use in pelvic floor physical therapy are unsuitable for internal pelvic trigger point therapy.
Furthermore, it is conventional in many areas of medicine to use temperature therapies, including hot (thermal) and cold (cryogenic) packs or baths, to battle symptoms of pain and discomfort. Heat and cold can be used alternatively and are often used as a prelude to exercise or physical therapy.
Heat therapy in particular is known to induce vasodilation and assist in drawing blood into the target tissues. The increased blood flow delivers needed oxygen and nutrients, and removes cell wastes. Heat is also known to decrease muscle spasms, relax tense muscles, relieve pain, and increase range of motion. There are available many devices and mechanisms to provide thermal therapy, including a variety of commercial hot packs, hot water bottles, hot towels/compresses, electrical moist heat devices, disposable self-heating patches, hot baths and hydrocollators. These conventional devices and mechanisms, however, are directed to provide generalized heat therapy by application to the skin, making them largely ineffective in the targeted therapy of the pelvic region with thermal therapy.
Conversely, cold therapy produces vasoconstriction, which slows circulation and reduces inflammation, muscle spasm, and pain. Cryogenic therapy devices are available in many forms including a variety of commercial cold packs, ice cubes, iced towels/compresses, and forms of hydrotherapy. Like with conventional thermal therapy devices and mechanisms, conventional cryogenic therapy devices and mechanisms are not suitable for providing targeted temperature therapy in the pelvic region.
There are several devices that are commercially available for providing cryotherapy at and just inside the anus for hemorrhoid relief. For example, U.S. Pat. No. 5,800,485 describes a system that uses a finger-shaped projection for insertion into the rectum. The projection is cooled by a cold fluid (such as cold water) that circulates through channels within the projection, thus providing generalized cooling to the surrounding tissue. The system uses an electrical pump to circulate the cooling fluid. The projection used in this system is relatively short and has substantially the same diameter over its length due to its function of treating swelling around the anal opening. The design of the projection thus make this system incapable of reaching deeply into the vaginal or rectal cavities of the patient and manipulated to deliver targeted pressure or temperature therapy at particular treatment points. Further, the system of this patent is fairly complicated, requiring the user to provide a cooling fluid and power (batteries or an electrical outlet) for the pump.
Similarly, the cryotherapy device marketed under the trade name “Hemor˜Rite” by FAMA Holdings International Corp. of Coral Springs, Fla., is adapted for applying cold therapy directly to the swollen hemorrhoidal veins to provide temporary relief of itching, pain, and swelling. The device comprises a traffic-cone shaped device that is filled with a ice-pack material that can be frozen in the freezer. The cone shaped device, once frozen, is directed for insertion into the rectum to deliver cold therapy generally in and around the area of the anus. The device is similar in shape to vaginal cones used for pelvic muscle exercising, having a substantial taper with its base being substantially larger in diameter than the distal end that pushes into the cavity. This shape makes the Hemo˜Rite device incapable of reaching deeply into the vaginal or rectal cavities of the patient to deliver targeted pressure or temperature therapy.
Thus, there remains a need for improved devices and related methods for using those devices in the relieving and/or treating of pain, discomfort, and/or inflammation in the pelvic region using targeted pressure and temperature therapy.